Home India Ministry of Health and Family Welfare The following draft of certain regulations further to amend ...
Date: 2016-04-29 Category: Extra Ordinary State: Union Government Country: India

The following draft of certain regulations further to amend the Food Safety and Standards Food Products Standards and Food Additives Regulations, 2011, which the Food Safety and Standards Authority of India

Issued by Ministry of Health and Family Welfare · Food Safety and Standards Authority

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Executive Summary & Key Takeaways

Executive Summary: This notification from the Food Safety and Standards Authority of India (FSSAI) publishes draft amendment regulations regarding Food Product Standards and Food Additives, specifically concerning packaged drinking water. The draft includes modifications to the standards for packaged drinking water. Objections or suggestions regarding these amendments must be submitted to the Chief Executive Officer of the FSSAI within thirty days of the notification's publication in the Official Gazette. The regulations will come into force on the date of their final publication in the official Gazette. Key Points / Main Content: Packaged Drinking Water Standards: * **Definition:** Packaged drinking water refers to water, excluding natural mineral water, intended for human consumption that is offered or sold in packaged form. * **Source and Treatment:** Water can be derived from surface, civic, underground, sea water, or any other consistent source. It must undergo specified treatments like decantation, filtration, and disinfection to meet safety standards. Sea water must be desalinated before treatment. * **Packaging:** The water must be filled into sealed containers suitable for direct consumption without further treatment. * **Remineralization:** If remineralization is part of the treatment, the ingredients used must be of food or pharma grade quality. * **Quality:** Packaged drinking water should be clear, free of sediments, suspended particles, and extraneous matter. * **Compliance:** The packaged drinking water must comply with the microbiological requirements outlined in Tables 1, Organoleptic and Physical parameters outlined in Table 2, parameters concerning substances undesirable in excessive amounts outlined in Table 3, parameters concerning toxic substances outlined in Table 4, parameters concerning radioactive residues outlined in Table 5 and parameters concerning pesticide residues outlined in Table 6 of the notification. Impact Analysis: Food Safety and Standards Authority of India: * Impact: Responsible for reviewing and considering objections and suggestions regarding the draft regulations. * Action Required: The Chief Executive Officer must receive and consider objections/suggestions to the draft regulations within 30 days of the Gazette publication. Packaged Drinking Water Manufacturers/Sellers: * Impact: Must comply with the revised standards for packaged drinking water, including source, treatment, packaging, and quality parameters. * Action Required: Review and adhere to the new regulations for packaged drinking water; may submit objections or suggestions to the FSSAI within the specified timeframe. Consumers: * Impact: Benefit from potentially improved quality and safety standards for packaged drinking water. * Action Required: No direct action required, but can provide feedback to the FSSAI.

Key Entities Referenced

Food Safety and Standards Authority of India: An authority that proposes to make regulations related to food safety and standards. Central Government: The government body that provides previous approval for the regulations made by the Food Safety and Standards Authority of India. Food Safety and Standards Act, 2006: The act under which the regulations are being made, specifically referring to section 16 and section 92. Food Safety and Standards Food Products Standards and Food Additives Regulations, 2011: The existing regulations being amended by this notification. Chief Executive Officer, Food Safety and Standards Authority of India: The person to whom objections or suggestions regarding the draft regulations should be addressed. New Delhi: Location of the Food and Drug Administration Bhawan and place of notification. Pawan Agarwal: The Chief Executive Officer of Food Safety and Standards Authority of India. Packaged Drinking Water: Subject of amendment in the regulations related to packaged drinking water standards.
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L.-33004/99 vlk/kj.k EXTRAORDINARY Hkkx III—[k.M 4 PART III—Section 4 izkf/dkj ls izdkf'kr PUBLISHED BY AUTHORITY la- 164] ubZ fnYyh] 'kqØokj] vçSy 29] 2016@oS'kk[k 9] 1938 No. 164] NEW DELHI, FRIDAY, APRIL 29, 2016/VAISAKHA 9, 1938 (cid:1)(cid:1)(cid:1)(cid:1)वव वव ाााा(cid:1)(cid:1)(cid:1)(cid:1)(cid:5)(cid:5) (cid:5)(cid:5) यय यय औऔऔऔरररर पपपप(cid:10)(cid:10)(cid:10)(cid:10)ररररववववाााारररर कककक(cid:12)(cid:12)(cid:12)(cid:12)यय यय ााााणणणण मममम(cid:16)(cid:16)ंं(cid:16)(cid:16)ंं ााााललललयययय ((((भभभभााााररररततततीीीीयययय खखखखाााा(cid:9)(cid:9)(cid:9)(cid:9) ससससररुुररुु (cid:12)(cid:12)(cid:12)(cid:12)ाााा औऔऔऔरररर ममममााााननननकककक (cid:17)(cid:17)(cid:17)(cid:17)ााााििििधधधधककककररररणणणण)))) अअअअििििधधधधससससचचूूचचूू ननननाााा नई (cid:4)द(cid:6)ली, 28 अ(cid:11)लै , 2016 फफफफाााा.... सससस..ंं..ंं 1111----11111111((((1111))))////ममममााााननननकककक////एएएएससससपपपपीीीी ((((जजजजलललल औऔऔऔरररर ससससुपुपुपुपययेेययेे ))))एएएएफफफफएएएएससससएएएएससससएएएएआआआआईईईई----2222000011115555....---- खा(cid:15) सुर(cid:19)ा और मानक (खा(cid:15) उ(cid:24) पाद मानक और खा(cid:15) सहयो(cid:29)य ) िविनय म, 2011 का और सशं ोधन करन ेके िलए ऐसे कितपय िविनयम’ का, िजनको (cid:4)क भारतीय खा(cid:15) सुर(cid:19)ा और मानक (cid:11)ािधकरण का, के+,ीय सरकार के पूव. अनमु ोदन स,े खा(cid:15) सरु (cid:19)ा और मानक अिधिनयम, 2006 (2006 का 34) क/ धारा 16 के साथ प1ठत धारा 92 क/ उपधारा (2) के खंड (ड.) 3ारा (cid:11)द(cid:24)त शि4य’ का (cid:11)योग करते 6ए बनान ेका (cid:11)8त ाव ह,ै िन9िलिखत (cid:11)ा:प धारा 92 क/ उपधारा (1) क/ अपे(cid:19)ानसु ार उन सभी @ि4य’ क/ जानकारी के िलए, िजनके उनसे (cid:11)भािवत होने क/ सभं ावना ह,ै (cid:11)कािशत (cid:4)कया जाता ह ै और यह सूचना दी जाती ह ै (cid:4)क उ4 िविनयम’ पर उस तारीख स,े िजसको भारत के उस राजपB क/, िजसम C यह अिधसचू ना (cid:11)कािशत क/ जाती ह,ै (cid:11)ितयां जनता को उपलDध करा दी जाती ह,E तीस (cid:4)दन क/ अविध क/ समािF के पGात् िवचार (cid:4)कया जाएगा; ऐसे आ(cid:19)ेप और सझु ाव, य़(cid:4)द कोई ह’, मLु य काय.पालक अिधकारी, भारतीय खा(cid:15) सरु (cid:19)ा और मानक (cid:11)ािधकरण, खा(cid:15) और औषिध (cid:11)शासन भवन, कोटला रोड, नई (cid:4)द(cid:6)ली-110002 को भेजे जा सकत ेह;E ऐसे आ(cid:19)ेप’ और सझु ाव’ पर, जो उ4 (cid:11)ा:प िविनयम’ के सबं ंध मC उपयु.Pत अविध के भीतर (cid:11)ाF ह’, भारतीय खा(cid:15) सरु (cid:19)ा और मानक (cid:11)ािधकरण 3ारा िवचार (cid:4)कया जाएगा। (cid:18)(cid:18)(cid:18)(cid:18)ाााा(cid:19)(cid:19)(cid:19)(cid:19)पपपप ििििववववििििननननययययमममम 1. इन िविनयम’ का सिं (cid:19)F नाम खा(cid:15) सरु (cid:19)ा और मानक (खा(cid:15) उ(cid:24) पाद मानक और खा(cid:15) सहयो(cid:29) य) (संशोधन) िविनयम, 2016 ह ै। (2) ये राजपB म Cउनके अंितम (cid:11)काशन क/ तारीख को (cid:11)वTृ ह’गे । 2.... खा(cid:15) सुर(cid:19)ा और मानक (खा(cid:15) उ(cid:24) पाद मानक और खा(cid:15) सहयो(cid:29) य) िविनयम, 2011 के िविनयम 2.10 के उपिविनयम 2.10.8 के 8थ ान पर, िनUन िलिखत उपिविनयम रखा जाएगा, अथात. ्:- 2084 GI/2016 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III —SEC. 4] ““““2222....11110000....8888 पपपपककैैककैै ेेेेजजजज बबबबददंंददंं पपपपययेेययेे जजजजलललल ((((पपपपैकैकैकैकेेेेजजजज बबबबददंंददंं (cid:18)(cid:18)(cid:18)(cid:18)ााााककककृृृृििििततततकककक खखखखििििननननजजजज जजजजलललल सससस ेे ेेििििभभभभ नन नन )))) 1. (cid:11)ाकृितक खिनज जल स ेिभV, ऐसा जल, िजसका मानव उपभोग के िलए (cid:11)योग (cid:4)कए जाने क/ सभं ावना ह ैऔर जो पकै ेज के :प म,C चाह ेवह (cid:4)कसी भी नाम स ेWात हो, पेश (cid:4)कया जाता ह ैया िवXय (cid:4)कया जाता ह।ै 2. ऐसा जल, जो सतही या िसिवल जल आपYू त अथवा भिू मगत जल या समु,ी जल या (cid:4)कसी अ+ य ि8थर जल Zोत से @(cid:24)ु पV (cid:4)कया जाता ह,ै िजसका (cid:4)क इसमC िविन[द\ट उपचार’, िजनके अ+त ग.त िन8 तारण, िन8 य+ दन, िन8 य+ दन का संयोजन, वातन, मेUब रेन िन8य +द क ((cid:4)फ(cid:6)ट र) के साथ िन8य + दन, अंतYव8 ता1रत (cid:4)फ(cid:6) टर, का^_ज (cid:4)फ(cid:6)ट र, स(cid:4)Xियत काबन. िन8 य+द न, िवखिनजीकरण, पुन: िवखिनजीकरण, (cid:11)तीप परासरण भी ह,ै के अधीन उपचार (cid:4)कया जाए और िजसे रासायिनक कमक. ’ या भौितक पaितय’ के माbय म स ेउसम Cसे खा(cid:15) सरु (cid:19)ा या उसक/ संधाय.ता के वWै ािनक :प स े 8व ीकृत 8 तर स े नीचे के 8त र तक सूcम जीवाणुd क/ सLं य ा को कम करने के िलए उस 8 तर तक िवसXं िमत करने के पeच ात,् िजस तक पेयजल म C कोई हािनकारक संदषू ण न हो, पैक (cid:4)कया जाता ह।ै पर+त ु सम,ु ी जल का उपरोPत उपचार (cid:4)कए जान े के पूव,. उसका अप(cid:19)ारीकरण करन े क/ तथा उसस े संबंिधत (cid:11)(cid:4)Xयाए ं क/ जाएंगी। 3. (1) इसे िभ+न -िभ+न सरं चनाd, :प’ और (cid:19)मताd वाले सीलबंद आधान’ म,C जो अित1रP त उपचार (cid:4)कए िबना सीधे उपयोग के िलए उपयुPत ह’, भरा जाएगा। (2) य(cid:4)द पनु : खिनजीकरण उपचार (cid:11)(cid:4)Xया का एक भाग ह,ै तो उसम C (cid:11)युPत संघटक खा(cid:15) hणे ी या भषे ज hेणी क/ Pव ािलटी के अनु:प ह’ग।े 4. (1) पकै ेज बंद पेयजल, (cid:4)क+ह i क(cid:6)क ’, िछतरे 6ए कण’ और बाk पदाथ .के िबना, 8 वl छ होगा। (2) यह नीचे दी गई सारणी 1,2,3,4,5 और 6 मC िन[द\ ट अपे(cid:19)ाd के भी अनु:प होगा। ससससााााररररणणणणीीीी 1111 :::: सससस""ूू""ूू मम मम जजजजववैैववैै ीीीीयययय अअअअपपपप%%ेे%%ेे ााााएएएए ंं ंं पपपपककैैककैै ेेेेज़ज़ज़ज़ बबबबददंंददंं पपपपय़य़ेेय़य़ेे जजजजलललल ििििनननन)))) नन ननििििललललििििखखखखतततत अअअअपपपप%%ेे%%ेे ाााा**** ककककेेेे अअअअनननन(cid:19)(cid:19)ुु(cid:19)(cid:19)ुु पपपप हहहहोोोोगगगगाााा:::: Xम. सं. ल(cid:19)ण अनुWेय सीमा (1) (2) (3) 1. ई8के1रि8या कोलाई (या तापसहनशील बैP टी1रया), सीएफय/ू250 िम.िल. अनुपि8थत 2. कोलीफाम. बैPट ी1रया, सीएफयू/250 िम.िल. अनुपि8थत 3. फ/कल 8_ ेnट ोकोकाई और 8ट ेफाइलोकोकस ऑ1रयस, सीएफय/ू250 िम.िल. अनुपि8थत 4. सा(cid:6)म ोनले ाटाईफ/, सीएफयू/250 िम.िल. अनुपि8थत 5. स(cid:6)फ ेट अवायवीय अवचायक, सीएफय/ू50 िम.िल. अनुपि8थत 6. सूडोमोनस ऐ:िगनोसा, सीएफयू/250 िम.िल. अनुपि8थत 7. वातापे(cid:19)ी (एअरोिबक) माइXोबाइल काउंट 100 72 घंटे मC 20-200 से. पर, सीएफयू/िम.िल., अिध. 24 घंटे मC 37± 10 स.े पर, सीएफयू/िम.िल., अिध. 20 8. यी8ट और फफूंद/250 िम.िल. अनुपि8थत 9. सा(cid:6)म ोनले ा और िशजेला, सीएफयू/250 िम.िल. अनुपि8थत 10. िवpो कोलरा और वी. पैराहीमोलाइटीकस, सीएफय/ू250 िम.िल. अनुपि8थत 5. पकै ेज बंद पेयजल, (cid:4)क+ह i कल क् ’, िछतरे 6ए कण’ और बाk पदाथ .के िबना, 8 वl छ होगा। यह सारणी 1,2,3,4, और 5 म C दी गई अप(cid:19)े ाd के भी अनु:प होगा।¹Hkkx IIIµ[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 3 ससससााााररररणणणणीीीी 2222 :::: आआआआगगगगनन00नन00 ोोोोललललििेेििेे1111टटटटकककक औऔऔऔरररर भभभभौौौौििििततततकककक पपपपैरैरैरैरााााममममीीीीटटटटरररर Xम. सं. ल(cid:19)ण अनुWेय सीमा (1) (2) (3) 1. रंग, वा8त िवक रंग इकाइयां, अिध. 2 2. गंध :िचकर 3. 8व ाद :िचकर [स(cid:4)Xय (cid:11)वृित मापमान (क) या (ख) या (ग)] 4. आिवलता, िमताई मिलनता इकाई (एनटीय)ू , अिध. 2 5. सUप ूण. िवलीन ठोस पदाथ., िम.qा./िल., अिध. 500 6. पीएच 6.0-8.5 ससससााााररररणणणणीीीी 3333 :::: अअअअ4444यय यय ििििधधधधकककक ममममाााा(cid:16)(cid:16)(cid:16)(cid:16)ाााा मममम 66 66अअअअववववााााछछंंछछंं ननननीीीीयययय पपपपददददााााथथथथ9999 सससस ेे ेेसससस)))) बब ब बिििि धधधधतततत ससससााााधधधधााााररररणणणण पपपपररैैररैै ााााममममीीीीटटटटरररर Xम. सं. ल(cid:19)ण अनुWेय सीमा (1) (2) (3) 1. बे1रयम (बीए के :प म)C , िम.qा./िल., अिध. 0.7 2. कॉपर (तांबा)(सीय ूके :प म)C , िम.qा./िल., अिध. 0.05 3. आयरन (लौह) (एफई के :प म)C , िम.qा./िल., अिध. 0.1 4. मEगनीज (एमएन के :प म)C , िम.qा./िल., अिध. 0.1 5. नाइ_ेट (एनओ के :प म)C , िम.qा./िल., अिध. 45 3 6. नाइ_ाइट (एनओ के :प म)C , िम.qा./िल., अिध. 0.02 2 7. rलओु राइड (एफ के :प म)C , िम.qा./िल., अिध. 1.0 8. tजक (जेडएन के :प म)C , िम.qा./िल., अिध. 5 9. िसलव ् र (एजी के :प म)C , िम.qा./िल., अिध. 0.01 10. ए(cid:6)य ुिमिनयम (एएल के :प म)C , िम.qा./िल., अिध. 0.03 11. Pल ोराइड (सीएल के :प मC), िम.qा./िल., अिध. 200 12. सेलिे नयम (एसई के :प म)C , िम.qा./िल., अिध. 0.01 13. स(cid:6)फ ेट (एसओ के :प म)C , िम.qा./िल., अिध. 200 4 14. ए(cid:6)क ािलिनटी ((cid:19)ारता) (एचसीओ के :प म)C , िम.qा./िल., अिध. 200 3 15. कैि(cid:6)eयम (सीए के :प म)C , िम.qा./िल., अिध. 75 16. मैuन ीिशयम (एमजी के :प म)C , िम.qा./िल., अिध. 30 17. सोिडयम (एनए के :प म)C , िम.qा./िल., अिध. 200 18. अविश\ट मुPत Pल ोराइड, िम.qा./िल., अिध. 0.2 19. फैनोिलक कUप ाउंड (योिगक)(सी एच ओएच के :प म)C अनुपि8थत 6 5 20. खिनज तेल अनुपि8थत 21. अैिनआिनक सतह स(cid:4)Xय कमक. (एमबीएएस के :प म)C , िम.qा./िल., अिध. 0.2 22. स(cid:6)फ ाइड (एच एस के :प म)C , िम.qा./िल., अिध. 0.05 24 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III —SEC. 4] Xम. सं. ल(cid:19)ण अनुWेय सीमा (1) (2) (3) 23. ए+ट ीमोनी (एसबी के :प म)C , िम.qा./िल., अिध. 0.005 24. बोरेvस (बी के :प म)C , िम.qा./िल., अिध. 5 25. pोमेvस (बीआरओ के :प म)C , िम.qा./िल., अिध. 0.01 3 ससससााााररररणणणणीीीी 4444 :::: ििििववववषषषषललैैललैै ेे ेेपपपपददददााााथथथथ :: ::सससस ेे ेेससससबबंंबबंं ििंंििंंधधधधतततत पपपपररैैररैै ााााममममीीीीटटटटरररर Xम. सं. ल(cid:19)ण अनुWेय सीमा (1) (2) (3) 1. पारा (एचजी के :प म)C , िम.qा./िल., अिध. 0.001 2. कैडिमयम (सीडी के :प म)C , िम.qा./िल., अिध. 0.003 3. आसिw नक (एएस के :प म)C , िम.qा./िल., अिध. 0.01 4. साइनाइड (सीएन के :प म)C , िम.qा./िल., अिध. अनुपि8थत 5. सीसा (पीबी के :प म)C , िम.qा./िल., अिध. 0.01 6. Xोिमयम (सीआर के :प म)C , िम.qा./िल., अिध. 0.05 7. िनकल (एनआई के :प म)C , िम.qा./िल., अिध. 0.02 8. पोलीPल ो1रन1े टड बाइ(cid:4)फनॉयल (पीसीबी) अनिभWेय 9. पोली+य ूPलीयर ऐरोम1े टक हाइyोकाब.+ स अनिभWेय ससससााााररररणणणणीीीी 5555 :::: ररररेेेेििििडडडडययययोोोो----धधधधमममम;;;; अअअअववववििििशशशश====टट टट >>>> ससससे े े े ससससबबंंबबंं ििंंििंंधधधधतततत पपपपररैैररैै ााााममममीीीीटटटटरररर Xम. सं. ल(cid:19)ण अनुWेय सीमा (1) (2) (3) 1. ए(cid:6)फ ा उ(cid:24)स जक. (इिमटस). , बे(cid:4)zरल (बीP यू/िल.), अिध. 0.1 2. बीटा उ(cid:24)स ज.क, बे(cid:4)zरल (बीPय ूएल), अिध; 1 ससससााााररररणणणणीीीी 6666 :::: ननननााााशशशशककककजजजजीीीीववववममममाााारररर ((((पपपप(cid:1)(cid:1)ेे(cid:1)(cid:1)ेे टट टटीीीीससससााााइइइइडडडड)))) अअअअववववििििशशशश====टट टट >>>> सससस ेे ेेससससबबंंबबंं ििंंििंंधधधधतततत ससससिििि????ययययमममम Xम. सं. ल(cid:19)ण अनुWेय सीमा (1) (2) (3) 1. नाशकजीवमार अविश\ट , िजन पर अलग-अलग :प मC िवचार (cid:4)कया गया ह।ै 0.0001 िम.qा./ िल. से अनिधक 2 कुल नाशकजीवमार अविशषट ् 0.0005 िम.qा./ िल. से अनिधक¹Hkkx IIIµ[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 5 6. उ(cid:24)प ाद,खा(cid:15) सुर(cid:19)ा और मानक (पैकेtजग और लेबtलग) िविनयम, 2011 के अधीन यथा अिधकिथत लेबtलग क/ अपे(cid:19)ाd के अन:ु प ह’गे।” पवन अqवाल, मुLय कायक. ारी अिधकारी [िवWापन-III/4/असा./46] (cid:10)(cid:10)(cid:10)(cid:10)टटटट1111पपपपणणणण :::: मूल िवि नय म भारत के राजपB, असाधारण, भाग-III, खंड 4 मC अिध सूचना सLं य ाकं फा.स.ं2-15015/30/2010, तारीख 1 अग8त , 2011 3ारा (cid:11)कािश त (cid:4)क ए गए थे उसके पeच ात् िन U निल िख त अिध सचू ना सं. 3ारा संशोधन (cid:4)क ए गए: (i) फा.सं. 4/15015/30/2011, तारीख 7 जून, 2013; (ii) फा.स.ं पी./15014/1/2011-पीफए/एफ़एसएसएआई, तारीख 27 जून, 2013; (iii) फा.स.ं 5/15015/30/2012, तारीख 12 जलु ाई, 2013; (iv) फा.स.ं पी.15025/262/2013-पीए/एफ़एसएसएआई, तारीख 5 (cid:4)दसंबर, 2014; (v) फा.स.ं 1-83एफ/एससीआई॰ पीएएन–अिध॰/एफ़एसएसएआई-2012, तारीख 17 फरवरी, 2015; (vi) फा.स.ं 4/15015/30/2011, तारीख 4 अग8त, 2015; (vii) फा.सं. पी. 15025/263/13-पीए/एफ़एसएसएआई, तारीख 4 नवUबर, 2015; (viii) फा.सं.पी॰15025/264/13-पीए/एफएसएसएआई, तारीख 4 नवUबर, 2015; (ix) फा.सं.पी.15025/261/2013-पीए/एफएसएसएआई, तारीख 13 नवUबर, 2015; (x) फा.सं.पी.15025/208/2013-पीए/एफएसएसएआई, तारीख 13 नवUबर, 2015; (xi) फा.सं.7/15015/30/2012, तारीख 13 नवUबर, 2015 और (xii) फा.सं.1-10(1)/8टै~ड(cid:127)स./एसपी((cid:4)फश एंड (cid:4)फश1रज (cid:11)ोडPvस)/एफएसएसएआई-2013, तारीख 11 जनवरी, 2016। MINISTRY OF HEALTH AND FAMILY WELFARE (FOOD SAFETY AND STANDARDS AUTHORITY OF INDIA) NOTIFICATION New Delhi, the 28th April , 2016 F. No.1-11(1)/Standards/SP(Water & Beverages)/FSSAI-2015.—The following draft of certain regulations further to amend the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011, which the Food Safety and Standards Authority of India proposes to make with previous approval of the Central Government in exercise of the powers conferred by clause (e) of sub- section (2) of section 92 read with section 16 of the Food Safety and Standards Act, 2006 (34 of 2006) is hereby published as required by the sub-section (1) of section 92, for information of all persons likely to be affected thereby and notice is hereby given that said draft regulations will be taken into consideration after the expiry of the period of thirty days from the date on which the copies of the Official Gazette in which this notification is published are made available to the public; Objections or suggestions, if any, may be addressed to the Chief Executive Officer, Food Safety and Standards Authority of India, Food and Drug Administration Bhawan, Kotla Road, New Delhi-110002; Objections and suggestions, which may be received with respect to the said draft regulations within the aforesaid period, will be considered by the Food safety and Standards Authority of India. Draft regulations 1. (1) These regulations may be called the Food Safety and Standards (Food Products Standards and Food Additives) Amendment Regulations, 2016. (2) They shall come into force on the date of their final publication in the official Gazette.6 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III —SEC. 4] 2. In the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011 in regulation 2.10, for sub-regulation 2.10.8, the following sub-regulation shall be substituted, namely:- “2.10.8 Packaged Drinking Water (other than Packaged Natural Mineral Water) 1. Water, other than natural mineral water which is likely to be used for human consumption and which is offered or sold in packaged form, by whatsoever name called, offered or sold. 2. Water shall be derived from surface or civic water supply or underground water or sea water or any other consistent source of water which may be subjected to herein under specified treatments, including decantation, filtration, combination of filtration, aerations, filtration with membrane filter depth filter, cartridge filter, activated carbon filtration, demineralization, remineralization, reverse osmosis and packed after disinfecting the water to a level that shall not lead to any harmful effect in the drinking water by means of chemical agents or physical methods to reduce the number of micro-organisms to a level below scientifically accepted level for food safety or its suitability. Provided that sea water, before being subjected to the above treatments, shall be subjected to desalination and related processes. 3. (1) It shall be filled in sealed containers of different compositions, forms and capacities that are suitable for direct consumption without further treatment; (2) In case remineralization is a part of the treatment process, the ingredients used shall conform to food grade or pharma grade quality. 4. (1) Packaged drinking water shall be clear without any sediments, suspended particles and extraneous matter; (2) It shall also comply with the requirements referred to in Tables 1, 2, 3, 4, 5 and 6 below:- Table 1: Microbiological Requirements Packaged drinking water shall comply with the following requirements: Sr. Characteristic Permissible Limit No. (1) (2) (3) 1. Escherichia coli (or thermotolerant bacteria), cfu / 250 ml Absent 2. Coliform bacteria, cfu/250 ml Absent 3. Faecal Streptococci, and Staphylococcus aureus, cfu /250 ml Absent 4. Salmonellatyphi, cfu /250 ml Absent 5. Sulphite Reducing Anaerobes, cfu/50 ml Absent 6. Pseudomonas aeruginosa, cfu/250 ml Absent 7. Aerobic Microbial Count 100 at 20-22o C in 72 h, cfu /ml, max at 37± 1o C in 24 h, cfu /ml, max 20 8. Yeast and mould/ 250 ml Absent 9. Salmonella and Shigella, cfu/250 ml Absent 10. Vibrio cholera, and V. parahaemolyticus cfu/250 ml Absent 5. Packaged drinking water shall be clear without any sediments, suspended particles and extraneous matter. It shall also comply with the requirements given in Tables 1, 2, 3, 4 and 5. Table 2 Organoleptic and physical parameters Sr. No. Characteristic Permissible Limit (1) (2) (3) 1. Colour, true colour units, Max 2 2. Odour Agreeable 3. Taste Agreeable [Action Tendency Scale a) or b) or c)]¹Hkkx IIIµ[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 7 4. Turbidity, nephelometric turbidity unit (NTU), Max 2 5. Total dissolved solids, mg/l, Max 500 6. pH 6.0 - 8.5 Table 3 General parameters concerning substances undesirable in excessive amounts Sr. Characteristic Permissible Limit No. (1) (2) (3) 1. Barium (as Ba), mg/l, Max 0.7 2. Copper (as Cu), mg/l, Max 0.05 3. Iron (as Fe), mg/l, Max 0.1 4. Manganese (as Mn), mg/l, Max 0.1 5. Nitrate (as NO ) mg/l, Max 45 3 6. Nitrite (as NO ), mg/l, Max 0.02 2 7. Fluoride (as F), mg/l, Max 1.0 8. Zinc (as Zn), mg/l, Max 5 9. Silver (as Ag), mg/l, Max 0.01 10. Aluminium (as Al), mg/l, Max 0.03 11. Chloride (as Cl), mg/l, Max 200 12. Selenium (as Se), mg/l, Max 0.01 13. Sulphate (as SO ), mg/l, Max 200 4 14. Alkaliniity (as HCO ), mg/l, Max 200 3 15. Calcium (as Ca), mg/l, Max 75 16. Magnesium (as Mg), mg/l, Max 30 17. Sodium (as Na), mg/l, Max 200 18. Residual free chloride, mg/l, Max 0.2 19. Phenolic compounds (as C H OH), Absent 6 5 20. Mineral oil Absent 21. Anionic surface active agents 0.2 (as MBAS), mg/l, Max 22. Sulphide (as H S), mg/l, Max 0.05 2 23. Antimony (as Sb), mg/l, Max 0.005 24. Borates (as B), mg/l, Max 5 25. Bromates (as BrO ), mg/l, Max 0.01 3 Table 4 Parameters concerning toxic substance Sr. Characteristic Permissible Limit No. (1) (2) (3) 1. Mercury (as Hg), mg/l, Max 0.001 2. Cadmium (as Cd), mg/l, Max 0.003 3. Arsenic (as As), mg/l, Max 0.01 4. Cyanide (as CN) Absent 5. Lead (as Pb), mg/l, Max 0.01 6. Chromium (as Cr), mg/l, Max 0.05 7. Nickel (as Ni), mg/l, Max 0.02 8. Polychlorinated biphenyle (PCB) Not detectable 9. Polynuclear aromatic hydrocarbons Not detectable8 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III —SEC. 4] Table 5 Parameters concerning radio-active residues Sr. Characteristic Permissible Limit No. (1) (2) (3) 1. Alpha emitters, Becquerel (Bq/l), Max 0.1 2. Beta emitters, Becquerel (Bq/l), Max 1 Table 6 Parameters concerning pesticide residues Sr. Characteristic Permissible Limit No. (1) (2) (3) 1. Pesticide residues considered individually Not more than 0.0001 mg/l 2. Total pesticide residue Not more than 0.0005 mg/l 6. The product shall comply with packaging and labelling requirements as laid down under the Food Safety and Standards (Packaging and Labelling), Regulations, 2011”. PAWAN AGARWAL, Chief Executive Officer [ADVT. III/4/Exty./46] Note.—The principal regulations were published in the Gazette of India, Extraordinary, Part III, Section 4, vide notification number F. No. 2-15015/30/2010, dated the 1st August, 2011 and subsequently amended vide notification numbers:- (i) F.No. 4/15015/30/2011, dated the 7th June, 2013; (ii) F.No. P.15014/1/2011-PFA/FSSAI, dated the 27th June, 2013; (iii) F.No. 5/15015/30/2012, dated the 12th July, 2013; (iv) F.No. P.15025/262/13-PA/FSSAI dated the 5th December, 2014; (v) F. No.1-83F/Sci.Pan-Noti/FSSAI-2012 dated the 17th February, 2015; (vi) F.No. 4/15015/30/2011, dated the 4th August, 2015; (vii) F.No P. 15025/263/13-PA/FSSAI, dated the 4th November, 2015; (viii) F.No. P.15025/264/13-PA/FSSAI, dated the 4th November, 2015; (ix) F.No P.15025/261/2013-PA/FSSAI, dated the 13th November, 2015; (x) F.No. P.15025/208/2013-PA/FSSAI, dated the 13th November, 2015; (xi) F.No. 7/15015/30/2012, dated the 13th November, 2015 and (xii) F.No.1-10(1)/Standards/SP(Fish and Fisheries Products)/FSSAI-2013, dated 11th January, 2016. Uploaded by Dte. of Printing at Government of India Press, Ring Road, Mayapuri, New Delhi-110064 and Published by the Controller of Publications, Delhi-110054.

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